Shared Health Appointments and Reciprocal Enhanced Support (SHARES)

• ClinicalTrials.gov Identifier: NCT02132676
• Recruitment Status: Completed
• First Posted: May 7, 2014
• Results First Posted: August 19, 2020
• Last Update Posted: September 2, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.

Condition or disease
Diabetes Insipidus

Detailed Description:

Providers are often unable to communicate as frequently as needed with diabetes patients who have poor risk factor control and face significant self-management challenges. Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project will evaluate the implementation of a novel program found in a recent VA randomized, controlled trial to significantly improve VA patients' diabetes-specific social support, insulin starts, and glycemic control compared to usual nurse care management. The program uses periodic group sessions in conjunction with calls between paired patients with diabetes to promote more effective care management as well as peer-to-peer (P2P) communication among diabetes patients who both have poor glycemic control and are working on similar care goals. "Peer buddies" are encouraged to talk by phone at least weekly to provide mutual support and share their progress on meeting their self-management goals. The goal of this service is to enhance the effect of shared medical appointments (SMAs), a service model demonstrated to be effective in improving outcomes among patients with diabetes and other chronic conditions and now being widely implemented in VA. Based on the success of the efficacy trial of this intervention, the investigators now seek to evaluate a wider-scale implementation of this program. During implementation of the P2P program in conjunction with shared medical appointments (SMAs) in five diverse VA facilities, the investigators will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to usual care, and study the implementation process in order to gather information required to disseminate the program more broadly in Veterans Health Administration (VHA).

Study Design

• Study Type: Observational
• Actual Enrollment: 1536 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems
• Actual Study Start Date: April 25, 2016
• Actual Primary Completion Date: June 28, 2019
• Actual Study Completion Date: July 30, 2019

Groups and Cohorts

Group/Cohort
Active treatment; All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered.
Usual Care; The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA).

Outcome Measures

Primary Outcome Measures :

1. Change in Glycemic Control [ Time Frame: 6 months and 12 months post-enrollment ]
   Glycemic control (measured by Hemoglobin A1c) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values of A1c, the investigators will also examine the change in the percentage of patients with an average A1c > 8%.

Secondary Outcome Measures :

1. Change in Systolic Blood Pressure (SBP) [ Time Frame: 6 months and 12 months post-enrollment ]
   Systolic blood pressure (SBP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, the investigators will also examine the change in percentage of patients with an average SBP > 140.
2. Insulin Starts [ Time Frame: 6 months and 12 months post-enrollment ]
   The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
3. Emergency Department (ED) Visits [ Time Frame: 6 months and 12 months post-enrollment ]
   Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
4. Statin Starts [ Time Frame: 6 months and 12 months post-enrollment ]
   The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
5. Change in Number of Classes of Anti-hypertensive Meds [ Time Frame: 6 months and 12 months post-enrollment ]
   Change in antihypertensive use (number of classes of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA.
6. Change in Patient-reported Satisfaction With VA Care [ Time Frame: 6 months and 12 months post-enrollment ]

   Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

   Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome

7. Change in Patient-reported Diabetes Distress [ Time Frame: 6 months and 12 months post-enrollment ]

   Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

   Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome

8. Change in Patient-reported Degree of Diabetes Support [ Time Frame: 6 months and 12 months post-enrollment ]

   Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

   Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome

9. Change in Patient-reported Degree of Self-Efficacy [ Time Frame: 6 months and 12 months post-enrollment ]

   Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used:

   Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome

10. Hospitalizations [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
11. Length of Hospitalizations [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
12. PCP Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
13. Nurse Case Manager Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
14. Endocrinology Visits [ Time Frame: 6 months and 12 months post-enrollment ]
    Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

VA outpatients with uncontrolled diabetes receiving care at a participating VA Medical Center during implementation of a P2P program for diabetes management in conjunction with SMAs

Criteria

Inclusion Criteria:

Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:

• Veteran receiving care at a participating VA Medical Center

• Meets at least one of the following criteria in the past 2 years;

  • at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
  • at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
  • At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies

• Poor glycemic control, indicated by a HbA1c in the past 6 months or:

  • at least 7.5% if age <70, or
  • at least 8% if age 70+
• Has a current address and telephone number listed in VA databases
• Is competent to provide informed consent
• Can communicate in English and by telephone
• Able to participate in an outpatient program

Exclusion Criteria:

For no intervention control group:

• Active substance abuse disorder (smoking cigarettes is not an exclusion)
• Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
• Terminally ill
• Prisoner

Contacts and Locations

Locations

United States, California

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States, 94304-1290

VA Northern California Health Care System, Mather, CA

Sacramento, California, United States, 95655

United States, Connecticut

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States, 06516

United States, Michigan

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105

United States, Rhode Island

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States, 02908

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Mary Ellen M Heisler, MD MPA; VA Ann Arbor Healthcare System, Ann Arbor, MI

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] June 19, 2020

More Information

Publications:

Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Jeffery SM, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. Trials. 2017 May 26;18(1):239. doi: 10.1186/s13063-017-1959-7.

Kowalski CP, Veeser M, Heisler M. Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption. BMC Fam Pract. 2018 Jul 7;19(1):109. doi: 10.1186/s12875-018-0797-3.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2021 Jun;36(6):1648-1655. doi: 10.1007/s11606-020-06570-y. Epub 2021 Feb 2.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02132676
• Other Study ID Numbers: IIR 15-321
• First Posted: May 7, 2014
• Results First Posted: August 19, 2020
• Last Update Posted: September 2, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Self-Management; Patient Care Management; Peer Group; Disease Management; Health Plan Implementation; Diabetes Mellitus

Additional relevant MeSH terms:

Diabetes Insipidus; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Pituitary Diseases